JPRN-UMIN000025772已完成未知
Placebo controlled double blind randomized Phase II Clinical Trial of sodium pyruvate on lactic acidosis associated with mitochondrial disorders (MELAS/MELA) - Placebo controlled double blind randomized Phase II Clinical Trial of sodium pyruvate on lactic acidosis associated with mitochondrial disorders (MELAS/MELA)
Japan Agency of Medical Research and Development0 个研究点目标入组 15 人开始时间: 2017年1月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
nfortunately, data obtained by the clinical trials could not prove the efficacy overall, though there are several patients with perfect improvement by clinical rating scales. After the strategy consultation to PMDA on October 18, 2018, we decided to terminate the SP project.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6years-old 至 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) patient who has bed ridden status 2) patient who has dementic status and cannot be evaluated the JMDRS/NMDAS by medical doctor 3) patient who has uncontrolled status epileptics 4) patient who has septic status 5) patient who has renal failre, and less than 60mL/min/1.73m by eGFR 6) patient who has hypertrophic cardiomyopathy or cardiac failre 7) patient who has allergic state against sodium pyruvate 8) patient who enrolled to the other clinical trial within 6 months 9) patient who has pregnant 10) patient who is not recommended to the entry by medical doctor
研究者
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